Tampa, Florida 33612

  • Lung Cancer, Protection Against

Purpose:

The purpose of this study is to find out if an investigational combination drug called Lovaza (made with fish oils)+Curcumin C3 Complex (made from a root called curcumin) can help reduce the size of lung nodules. Researchers also want to find out if the combination of Lovaza+Curcumin C3 Complex is safe and tolerable.


Criteria:

Inclusion Criteria: - Male or female, 55 years of age or older - Former smokers and current enrolled in LDCT lung cancer screening or those who are detected using a regular CT, and have Lung-RADS 3 category lesion(s), that would get a 6 month f/u LDCT or regular CT based on Lung-RADS recommendations or former and current smokers enrolled in LDCT lung cancer screening, or regular CT and have Lung-RADS 2 category lesions with persistent or slowly increasing part-solid or non-solid lung nodule >4mm mean diameter detected by two serial yearly screening low dose CT or regular CT scans. - History of cigarette smoking with ≥ 20 pack years - All current smokers should accept to receive smoking cessation - Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1 - Able to swallow study pills - Able to undergo CT - Not allergic to components of study agents - Willing to discontinue current vitamin/mineral supplement use containing components of study agents. A standard multivitamin supplement provided for the study - Willing to comply with proposed visit and treatment schedule - Able to understand and willing to sign a written informed consent document - Participants must have normal organ and marrow function - Willing to use contraception during the intervention period of 6 months (males and females) - Not pregnant or lactating nor planning to become pregnant or lactate during the 6 month study intervention period.. Exclusion Criteria: - Invasive cancer diagnosis (excluding basal cell carcinoma or skin squamous cell carcinoma) diagnosed within the last 2 years - Inability to undergo CT - Newly diagnosed nodule meeting Lung-RADS 4 criteria - Have taken doxycycline or tetracycline less than or equal to 2 weeks - Females- pregnant or lactating (throughout the duration of intervention of 6 months) - Unwilling to use effective form of birth control (Males and females) (throughout the duration of intervention of 6 months).


Study is Available At:


Original ID:

MCC-19622


NCT ID:

NCT03598309


Secondary ID:

8JK03


Study Acronym:


Brief Title:

Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers


Official Title:

Phase II Trial of Investigational Agents to Modulate Intermediate Endpoint Biomarkers, Including Pulmonary Nodules, in Former and Current Smokers


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

55 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

H. Lee Moffitt Cancer Center and Research Institute


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

75


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Nagi Kumar, Ph.D
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute

Study Dates

Start Date:June 5, 2019
Completion Date:October 2023
Completion Type:Anticipated
Primary Completion Date:October 2022
Primary Completion Type:Anticipated
Verification Date:January 2021
Last Changed Date:May 25, 2021
First Received Date:July 13, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Rate of Treatment Related Adverse Events (AEs)
Time Frame:Up to 30 days post treatment, approximately 7 months
Safety Issues:False
Description:Safety of the combined agents (Curcumin C3 complex® + Lovaza®) at 2 dose arms vs. placebo as indicated by incidence of related adverse events and toxicities, monitored using Common Toxicity Criteria version 5.0.
Outcome Type:Secondary Outcome
Measure:Rate of Adherence
Time Frame:6 months post treatment
Safety Issues:False
Description:Rate of participant adherence per study arm. Proof of adherence based on study team pill counts, participant diet logs and pill logs at end of study, vs. data collected at midpoint.
Outcome Type:Primary Outcome
Measure:Rate of Nodules ≥4 mm
Time Frame:6 months post treatment
Safety Issues:False
Description:Number of nodules ≥4 mm per study arm, post treatment.
Outcome Type:Primary Outcome
Measure:Mean Change in Bronchial Nodule Size
Time Frame:6 months post treatment
Safety Issues:False
Description:Difference in the average change in bronchial nodule size from baseline to end of therapy at 6 months for each study arm. A lower size is taken to be the desired value for participants receiving study drug, assuming an increase in size for the placebo arm

Study Interventions

Intervention Type:Other
Name:Placebo
Description:Groups B and Placebo as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Arm Name:Curcumin C3 complex® +Lovaza® +Placebo
Other Name:Pill with no drug or other active ingredients in i
Intervention Type:Drug
Name:Lovaza®
Description:Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Arm Name:Curcumin C3 complex® +Lovaza®
Other Name:Omega-3-Acid Ethyl Esters
Intervention Type:Drug
Name:Curcumin C3 complex®
Description:Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Arm Name:Curcumin C3 complex® +Lovaza®
Other Name:Curcuminoid

Study Arms

Study Arm Type:Active Comparator
Arm Name:Placebo only
Description:Placebo: Two matching placebo capsules twice a day (BID), taken by mouth, AM and PM
Study Arm Type:Active Comparator
Arm Name:Curcumin C3 complex® +Lovaza® +Placebo
Description:Group B: 2 grams Lovaza®, 1 gram twice a day, AM and PM. 4,000 mgs CUR Curcumin C3 complex® tablets, 2,000 mgs twice a day, AM and PM. 1 placebo capsule twice a day, AM and PM.
Study Arm Type:Active Comparator
Arm Name:Curcumin C3 complex® +Lovaza®
Description:Group A: 4 grams Lovaza®, 2 grams twice a day (BID). 2 grams by mouth daily, AM and PM 8,000 mgs CUR Curcumin C3 complex® tablets, divided into 2 doses. 4 grams by mouth, twice a day, AM and PM.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:H. Lee Moffitt Cancer Center and Research Institute
Agency Class:Other
Agency Type:Collaborator
Agency Name:James and Esther King Biomedical Research Program

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 25, 2021

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